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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name wire, guide, catheter
510(k) Number K014075
Device Name BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145
Applicant
BAYLIS MEDICAL CO., INC.
5160 EXPLORER DRIVE, UNIT 33
MISSISSAUGA, ONTARIO,  CA L4W-4T7
Applicant Contact KRIS SHAH
Correspondent
BAYLIS MEDICAL CO., INC.
5160 EXPLORER DRIVE, UNIT 33
MISSISSAUGA, ONTARIO,  CA L4W-4T7
Correspondent Contact KRIS SHAH
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/11/2001
Decision Date 03/07/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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